Study to assess the safety of the study drug IPI-145/Duvelisib or ofatumumab in leukemia patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 307

Inclusion Criteria

Subjects are eligible for inclusion in this extension study if they meet the following criteria:
1.Received either duvelisib or ofatumumab while participating in Study IPI 145-07 and experienced radiologically-confirmed disease progression
2.Diagnosis of active CLL or SLL that meets at least one of the IWCLL 2008 criteria for requiring treatment (Binet Stage = B and/or Rai Stage = I)
3.Measurable disease with a lymph node or tumor mass >1.5 cm in at least one dimension as assessed by computed tomography (CT)
4.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (corresponds to Karnofsky Performance Status [KPS] =60%)
5.Must meet the following laboratory parameters:
a)Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) =3 x upper limit of normal (ULN)
b)Total bilirubin =1.5 x ULN
c)Serum creatinine =2.0 x ULN
d)Hemoglobin =8.0 g/dL with or without transfusion support
e)Platelet count =10,000 µL with or without transfusion support
6.For women of childbearing potential (WCBP): negative serum ß-human chorionic gonadotropin (ßhCG) pregnancy test within 1 week before first dose (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 24 consecutive months [women =55 years] or 12 consecutive months [women >55 years])
7.Willingness of male and female subjects who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control from the first dose of study drug to 30 days after the last dose of duvelisib and for 12 months after last dose of ofatumumab. Sexually active men, and women using oral contraceptive pills, should also use barrier contraception
8.Ability to voluntarily sign consent for and adhere to the entire study visit schedule and all protocol requirements
9.Signed and dated institutional review board (IRB)/independent ethics committee (IEC)-approved informed consent form (ICF) before any study specific screening procedures are performed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 302
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Subjects are to be excluded from the study if they meet any of the following criteria:
1.Discontinued study participation in Infinity-sponsored IPI-145-07
2.>3 months from confirmed progressive disease (PD) on Study IPI-145-07
3.Richter’s transformation or prolymphocytic leukemia
4.Autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP) that is uncontrolled or requires >20 mg daily (QD) of prednisone (or equivalent) to maintain hemoglobin >8.0 g/dL or platelets >10,000 µL without transfusion support.
5.Known central nervous system (CNS) lymphoma or leukemia; subjects with symptoms of CNS disease must have a negative computed tomography (CT) scan or negative diagnostic lumbar puncture prior to first dose
6.Use of any anticancer medication from documented PD on Study IPI-145-07 to enrollment
?Note: corticosteroids to manage CLL/SLL-related symptoms are allowed
7.Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment (defined as requiring IV antimicrobial, antifungal or antiviral agents)
?Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met and there is no evidence of active infection at Screening and/or Cycle 1 Day 1 (predose)
8.Human immunodeficiency virus (HIV) infection
9.Prior, current or chronic hepatitis B or hepatitis C infection
10.History of alcohol abuse or chronic liver disease (other than metastatic disease to the liver)
11.Unable to receive prophylactic treatment for pneumocystis and herpes simplex virus (HSV)
12.Baseline QT interval corrected with Fridericia’s method (QTcF) >480 ms (average of triplicate readings) NOTE: this criterion does not apply to subjects with a right or left bundle branch block (BBB)
13.Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix, bladder, or prostate not requiring treatment. Subjects with previous malignancies are eligible provided that they have been disease-free for =2 years
14.History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
15.Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition), or any important medical illness or abnormal laboratory finding that would, in the Investigator’s judgment, increase the subject’s risk while participating in this study
16.Prior surgery or gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
17.Subjects to receive duvelisib: Administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A within 2 weeks of starting duvelisib
18.Major surgery or invasive intervention within 4 weeks prior to first dose
19.Pregnant or breastfeeding women
20.Subjects to receive ofatumumab: hypersensitivity to ofatumumab or its excipients.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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